BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPLITTABLE SHEATH INTRODUCER SET

    K Number: K920634 · Decision Jan 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    64
    Applicant Total
    36
    Review Days
    702

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    Basic Information

    Device Name
    SPLITTABLE SHEATH INTRODUCER SET
    K Number
    K920634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Akcess Medical Products, Inc.
    Date Received
    February 12, 1992
    Decision Date
    January 14, 1994
    Product Code
    LFJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LFJ Catheter, Subclavian

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